The overall goal of this project is to continue development and commercialization of a Balance Sensory Augmentation and Substitution System (B-SASS). The device termed Walkasins"""""""" measures foot pressure through a thin sole insert, developed under recent Phase I funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. The device can either substitute lost foot pressure sensation;e.g. in individuals with peripheral neuropathy or it can act as a """"""""balance booster"""""""" providing an augmentation of sensory information to individuals with general balance problems. The device can be worn in bed at night and turns on automatically when the wearer gets out of bed to go, e.g. to the bathroom. We have acquired pilot data demonstrating that clinical parameters reflecting gait balance and mobility improve when elderly at-risk fallers use the device bringing them to non- faller status. For the current Phase II proposal our specific aims are to: 1. Revise and finalize design of Walkasins"""""""" based on accomplishments, user input, as well as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for clinical testing. Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2 2. In a double-blind randomized control trial investigate effects of using Walkasins"""""""" on clinical outcomes related to gait, balance functio and associated fall risk in a hospital-based outpatient rehabilitation program at the Sister Kenny Rehabilitation Institute in Minneapolis. Hypotheses 1A-C: Patients who participate in a comprehensive outpatient rehabilitation program and use Walkasins"""""""" programmed to display relevant balance cues will attain higher gait speed, Functional Gait Assessment and Balance Confidence following their episode of care when compared to a matched cohort using Walkasins"""""""" programmed to vibrate similarly although unrelated to balance. Hypothesis 2: Patients who use Walkasins"""""""" on a daily basis during their episode of care will not experience issues related to skin irritation. Milestone 2: Data confirming the clinical utility and long-term se safety of the Walkasins"""""""" on patients'participating in a hospital-based comprehensive outpatient rehabilitation program.

Public Health Relevance

Loss of balance function can lead to falls resulting in injury and even death. This project will continue development and commercialization of a wearable balance prosthetic device that can enhance balance and mobility. The device, termed Walkasins, measures foot pressure in real time and provides foot pressure information to the subject through a vibrotactile feedback array, placed around the lower leg. The device can either substitute lost foot pressure sensation, e.g. in individuals with peripheral neuropathy, or t can act as a balance booster providing an augmentation of sensory information to individuals with general balance problems.